- Innovative Phase 1b trial of SNT-9465 in hypertrophic scars exceeds 50% recruitment
- Pilot cohort data confirm high baseline lysyl oxidase activity, validating the choice of scar type for the trial
- Ongoing Fiona Wood Foundation / University of Western Australia exploratory clinical trial in keloid scarring progressing in parallel
- Syntara entering a news-rich period, with multiple clinical trial milestones expected over the coming months.
Syntara Limited (ASX:SNT), a clinical-stage drug development company, is pleased to announce that recruitment in the Phase 1b study of its next-generation topical pan-lysyl oxidase (pan-LOX) inhibitor SNT-9465 in hypertrophic scars is progressing well, with 60% of participants now having commenced treatment. A recent social media campaign has identified additional patients and boosted recruitment, which is expected to close in Q3 2026.
The Phase 1b study is a randomised, double-blinded, placebo-controlled trial in 20 adult participants with hypertrophic sternotomy scars. The study is enrolling individuals with recent scars (6-24 months). Participants are receiving blinded active treatment and placebo applied to distinct regions of the same scar, separated by buffer, for a three-month treatment period. At the end of treatment, scar regions will be evaluated using a suite of state-of-the-art imaging and assessment tools.
The baseline LOX activity observed in biopsies from five participants with scars less than 24 months old was markedly higher than that observed in the earlier SOLARIA2 study, when the average scar age was 13 years. Although there are differences in aetiology and location of the scars between the studies (burns vs surgical) it is anticipated that higher LOX levels may drive faster tissue turnover within the scar, creating a greater opportunity for a pan-LOX inhibitor to remodel scar architecture.
A range of recruitment approaches has been employed, confirming that there is a substantial pool of patients seeking treatment for hypertrophic scars. Top-line results remain on track for 2026 and are intended to support an FDA Investigational New Drug (IND) application, paving the way for a global development program targeting the first approved pharmacological treatment for skin scarring.
Syntara CEO Gary Phillips said,
“This is an innovative and pioneering study, and it’s encouraging to see patients coming forward for treatment and such strong engagement in the trial centres as we work towards completing recruitment in Q3 2026. Our choice of scar type has been vindicated by the high levels of LOX activity observed in participants’ scars prior to treatment; LOX is clearly an important driver of scar formation, and we have a genuine opportunity to demonstrate a clinically meaningful benefit for these participants later this year.”
In parallel, the exploratory UWA Investigator Initiated Study, SATELLITE, is looking at the effect of the first-generation topical pan-LOX inhibitor SNT-6302 on keloid scars – which have a significantly different biology from the hypertrophic scars studied in the ongoing SNT-9465 trial. SATELLITE has now reached an interim point, with a significant number of patients completing three months of treatment. These patients will now be monitored by UWA investigators for an extended period after stopping treatment to assess how lysyl oxidase inhibition influences the biology of their scars over time. This data will increase the understanding of the remodelling of scar tissue in keloids and may help define which keloid scar subtypes are more susceptible to lysyl oxidase inhibitors and could be targeted in future clinical programs.
Syntara is entering a news-rich period, with multiple clinical trial milestones expected over the coming months, including preliminary results from the iRBD Parkinson’s disease study of SNT-4728, which are anticipated shortly.
